Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ECHELON CIRCULAR Powered Stapler

K-Number: K163523 · 2017-04-18

ApplicantEthicon Endo-Surgery, LLC
Decision Date2017-04-18
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECHELON CIRCULAR Powered Stapler is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2017-04-18 under approval number K163523. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHELON CIRCULAR Powered Stapler?

ECHELON CIRCULAR Powered Stapler is a medical device that received FDA 510(k) clearance on 2017-04-18. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K163523.

When was ECHELON CIRCULAR Powered Stapler approved by the FDA?

ECHELON CIRCULAR Powered Stapler received FDA 510(k) clearance on 2017-04-18, under approval number K163523.

What company makes ECHELON CIRCULAR Powered Stapler?

ECHELON CIRCULAR Powered Stapler is manufactured by Ethicon Endo-Surgery, LLC.

What is the FDA product code for ECHELON CIRCULAR Powered Stapler?

The FDA product code for ECHELON CIRCULAR Powered Stapler is GDW.

Related Clinical Trials

NCT05360069 Linear Stapler Versus Circular Stapler in Esophagojejunostomy RECRUITING

Other Devices by Ethicon Endo-Surgery, LLC

K160554Enseal X1 Large Jaw Tissue Sealer K160128Endopath Electrosurgery Probe Plus II K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm K151136HARMONIC HOOK K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length K163548ENSEAL X1 Large Jaw Tissue Sealer

View all 33 devices →

Related Devices (Code: GDW)

K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and ReloadsVictor Medical Instruments Co., Ltd. K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler CartridgeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd K162252FasTouch Fixation SystemVia Surgical , Ltd. K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑